Actively Recruiting
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Led by VA Office of Research and Development · Updated on 2025-11-10
66
Participants Needed
4
Research Sites
270 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
CONDITIONS
Official Title
Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Eastern Cooperative Group (ECOG) performance status of 0 to 2
- Newly diagnosed histologically or cytologically confirmed stage IV Non-Small Cell Lung Cancer (NSCLC) or locally advanced NSCLC not suitable for definitive therapy but eligible per investigator
- Body Mass Index (BMI) of at least 19 kg/m2
- Enrollment before starting standard care immunotherapy (PD-(L)1 inhibitor alone, specifically pembrolizumab) for stage IV NSCLC
- Patients may have completed palliative or definitive radiation to oligometastatic disease prior to immunotherapy, after recovery from toxicities
You will not qualify if you...
- Self-reported weight loss of more than 10% in the 6 weeks before study entry
- History of symptomatic hypoglycemia or uncontrolled diabetes
- Prior therapies with insulin growth factor I (IGF-1) inhibitors like Linsitinib or Picropodophyllin
- Current use of somatostatin
- Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
- Significant food allergies preventing consumption of study-provided food
- History or current uncontrolled medical or psychiatric conditions or therapies that could affect study participation or safety
- Pregnant or lactating females are not eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
2
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Actively Recruiting
3
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Actively Recruiting
4
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106-1621
Actively Recruiting
Research Team
S
Shadia Jalal, MD
CONTACT
A
Aleksandra Radovanovich, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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